MAUDE Adverse Event Report: D R BURTON HEALTHCARE, LLC VPEP; OPEP

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Reference # mw5067507 and (b)(4).As a response to the mdr report number mw5067507, d r burton healthcare, llc performed an investigation into the claims made and provides the following manufacturer update: to date d r burton has had no direct complaints from any customers, there was no healthcare professional information provided to pursue the basis of this claim, no product was returned, and post market surveillance; we contacted 100% of our customers and 0% reported any problems with this reported issue or any other product concerns.

Event Description

Reference #: mw5067507 and (b)(4).

• Brand Name: VPEP
• Type of Device: OPEP
• Manufacturer (Section D): D R BURTON HEALTHCARE, LLC; 3936 south fields street; farmville NC 27828
• Manufacturer (Section G): D R BURTON HEALTHCARE, LLC; 3936 south fields street; farmville NC 27828
• Manufacturer Contact: janice jones ; 3936 south fields street; farmville, NC 27828 ; 2522287047
• MDR Report Key: 6504626
• MDR Text Key: 73223612
• Report Number: 3012970776-2017-00001
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• PMA/PMN Number: K991561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1